BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10-PACK OVERTAPE ASSEMBLY, ENLITE

    MDR report key: 4231333 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48398
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A ENLITE SENSOR POP OUT. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 34 MG/DL. THE CUSTOMER'S TREATED HIMSELF AFTER THE BLOOD GLUCOSE READING. THE CUSTOMER SENSOR POP OUT BECAUSE OF STRENUOUS EXERCISE ((B)(4)). THE CUSTOMER WAS ADVISED TO DISCUSS THE USE OF CLEANSER LIKE SKIN PREP. THE CUSTOMER HAD JUST RECEIVED A NEW SET OF SENSORS AND WE WILL ISSUE A BOX OF IV300 AS COURTESY TO AVOID USING OVERTAPE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714987 10-PACK OVERTAPE ASSEMBLY, ENLITE CGM MDS MEDTRONIC MINIMED 7005739-002

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening